GDPMD and Quality System Requirements for Thai Importers

The licence-holding importer in Thailand must operate its own quality system. This page explains GDPMD, the Good Distribution Practice for Medical Devices, its legal basis alongside the 2023 GMP requirements, what GDPMD actually governs, the inspection exposure, and why GDPMD and ISO 13485 answer different questions and cannot substitute for one another.

1. Key takeaways

Yes, a licensed importer needs a quality system of its own. The licensed importer must maintain GDPMD, the Good Distribution Practice for Medical Devices, or an equivalent quality management system, and must accept Thai FDA inspection. This is the corporate-side quality system requirement, running in parallel with the manufacturer-side ISO 13485 requirement. Both are needed: the manufacturer’s system does not cover distribution, and the importer’s system does not cover production.

• Manufacturer side. Manufacturers must comply with the GMP requirements, with compliance demonstrated by holding one of a GMP certificate, a TCAS 13485 certificate or an ISO 13485 certificate. Manufacturers of low-risk Class 1 devices are exempt from certification, but must still upgrade their facilities and establish a quality system meeting the new GMP standard.
• Import and distribution side. The licensed importer must comply with the Good Import and Distribution Practice, which in practice means maintaining GDPMD.
• Inspection exposure. Site inspections of the institutional licence target whether the office and warehouse premises meet storage and quality system requirements, and the Thai FDA also checks GDPMD maintenance in routine supervision.
• Selection criterion. GDPMD maintenance evidence should be on the checklist when selecting a Thai licence-holding partner.

2. Legal basis

The quality system framework for medium and high-risk devices rests on two instruments issued together: the Thai GMP Notification B.E. 2566 (2023) and the Good Import and Distribution Practice Notification B.E. 2566 (2023). The GMP notification governs the manufacturer side and requires compliance with GMP requirements, demonstrated through one of three acceptable certificates: a GMP certificate, a TCAS 13485 certificate or an ISO 13485 certificate. Manufacturers of Class 1 devices, the low-risk tier, are exempt from certification but must still upgrade their facilities and establish a quality system conforming to the new GMP standard. The Good Import and Distribution Practice notification governs the import and distribution side and imposes the corresponding obligations on the licensed importer, realised in practice through the maintenance of GDPMD. Record keeping for imports and sales runs alongside this framework, with a retention requirement of no less than five years.

3. Expert insights

The first question most foreign manufacturers ask is whether the licensed importer really needs a quality system of its own, and the answer is unambiguously yes. The licensed importer must maintain GDPMD or an equivalent quality management system and must accept Thai FDA inspection. The requirement is often underestimated because the manufacturer already holds ISO 13485, but the Thai framework deliberately splits the quality burden along the supply chain: the manufacturer certifies production, and the importer certifies what happens to the product after it lands in Thailand.

GDPMD governs quality management across the entire import and distribution process. Its core elements are storage conditions, which must conform to the preservation requirements stated in the device instructions, with warehouses required to be ventilated, dry, clean and away from sources of contamination; transport conditions, where vehicles must suit the type of device; traceability and records, with import and sales records retained for at least five years; personnel qualifications; and quality system documentation together with internal audits.

The relationship between GDPMD and ISO 13485 is best understood as different subjects and different standards. ISO 13485 governs the design and production of the manufacturer; GDPMD governs the procurement, warehousing and distribution of the importer. A licensed importer cannot use its own ISO 13485 certificate to replace GDPMD, and cannot use the manufacturer’s ISO 13485 certificate to replace its own system either. The two certifications answer different questions about different facilities and different processes, so presenting a manufacturer’s certificate to satisfy an importer obligation is a category error that will surface at the first inspection.

On inspection, the site inspection of the institutional licence is precisely the checkpoint at which office and warehouse premises are assessed against storage and quality system requirements, and the Thai FDA also examines GDPMD maintenance in the course of routine supervision, so the exposure is continuous rather than confined to licensing events.

4. Practical recommendations

• When selecting a Thai licence-holding partner, add GDPMD maintenance evidence to the verification checklist alongside the institutional licence and the certificates held in the partner’s own name.
• Request three specific items of evidence from the partner: a warehouse floor plan and location map, records of storage conditions such as temperature and humidity, and the quality system documentation related to GDPMD.
• Read the three items as a direct test of whether the partner is a capability-based licence holder or a channel-based licence holder: a partner that can produce the plan, the records and the documentation on demand is running a real distribution operation, while one that cannot is offering little more than a name on a certificate.
• Confirm that the partner’s storage facilities conform to the preservation requirements stated in the device instructions, including ventilation, cleanliness and separation from contamination sources, and that transport arrangements suit the device type.
• Keep the five-year import and sales records organised under the same system, since the record retention duty and the GDPMD duties are checked together in practice.

5. Verification checklist

• □ Confirm the MoPH GMP Notification B.E. 2566 (2023).
• □ Confirm the MoPH Good Import and Distribution Practice Notification B.E. 2566 (2023).
• □ Confirm the GDPMD requirements applicable to licensed importers.
• □ Confirm the manufacturer-side compliance routes: a GMP certificate, a TCAS 13485 certificate or an ISO 13485 certificate, one of three.
• □ Confirm that Class 1 devices are exempt from certification but must still conform to the GMP standard.
• □ Confirm the Thai FDA site inspection: office and warehouse premises must meet storage and quality system requirements.
• □ Confirm retention of import and sales records for at least five years.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Thailand. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the Thai FDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com